FDA product code · Neurology

Laser, Neurosurgical

Name: FDA decisions, review times, recalls and adverse event reports for product code LKW
Creator: 510(k) Report

LKWClass IIIPathway set case by case5 decisions since 19850 recalls

5 FDA decisions since 1985. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, neurology panel

Twenty years of LKW at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · LKW

FDA has decided no LKW device since 2007.

Median 510(k) review, days · LKW

Too few LKW 510(k)s in any year since 2007 to give a median.

Recalls per year · LKW

No recall names LKW since 2007.

Adverse event reports per year · LKW

No MAUDE report names LKW since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — LKW by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LKW? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Laser, Neurosurgical

What has FDA decided in LKW lately?